Lead Engineer, Equipment Commissioning & Qualification (ECQ) Delivery

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Purpose of the Position:

The Lead Engineer, Equipment Commissioning & Qualification (ECQ) Delivery supports the successful operation of facility, laboratory and business functions at multi-use sites through interaction with internal customers and external service providers. The incumbent in this role, identifies issues or unmet needs and initiates projects or programs to address them. This individual works independently to complete assignments and oversees the successful completion of tasks. Using solid analytical skills, the incumbent is able to recognize problems of moderate scope and complexity, and independently, develop potential solutions and courses of action. This individual represents the work group on multi-disciplinary and cross-functional teams and uses established relationships to influence and lead teams and stakeholders with fact-based, business value knowledge.

Essential Functions:

Maintains all qualified equipment systems in compliance with policies, guidelines and procedures:

Initiates, manages and leads projects of moderate scope and complexity within their functional area.

Manages equipment implementation projects including scheduling, procurement, site prep, installation, qualification, and turn over to business area.

Provides guidance to internal customer groups in the procurement, operation, calibration, and preventive maintenance of equipment to meet business needs in accordance with required schedules or dates.

Supports facilities new construction and relocation projects.

Reviews all calibration, qualification and validation documentation for accuracy, completeness and compliance to Celgene standards.

Provides technical knowledge and direction as Equipment Commissioning & Qualification site representative during interactions with all cross functional groups, as required.

Promotes and provides excellent customer service and support

Regularly reviews, prioritizes and promptly responds to customer equipment qualification and support requests.

Provides technical support and guidance on equipment and computer systems qualification and validations issues. Interfaces with customers to ensure all expectations are being met.

Maintains a positive relationship with all the members of the Equipment Commissioning & Qualification department and site customers while promoting a positive team environment.

Regulatory Responsibilities

Ensure equipment, facilities and programs are maintained in compliance.

Act as departmental lead and SME in both internal and regulatory audits.

Required Competencies‐Knowledge, Skills, and Abilities:

Education & Experience:

BS in Engineering or Science related discipline preferred.

Minimum of 5 years’ experience in FDA-regulated industry. with 5 years experience in equipment qualification.

Knowledge of cGMP in the pharmaceutical industry.

Must have strong interpersonal and communication skills, be a team player and be willing to work in an environment where individual initiative, accountability to the team, and professional maturity are required

Primarily office environment, but will be required to enter laboratory or GMP process areas donning proper gowning / lab coats or PPE such as safety glasses and shoes.

Ability to work safely and effectively when working alone, or working with others.

Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.